Actively Recruiting
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Led by Kai Hu · Updated on 2025-02-12
24
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT1190B CAR-T Cell therapy, in Patients with Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma.
CONDITIONS
Official Title
A Clinical Study Exploring CT1190B in the Treatment of Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign informed consent and agree to follow study visits and long-term follow-up for up to 15 years
- Age between 18 and 75 years
- Histologically or cytologically confirmed diagnosis of B-cell Non-Hodgkin Lymphoma
- Previously received at least two lines of systemic therapy
- Intolerance to last treatment or progression requiring new therapy
- Measurable target lesions present
- Expected survival longer than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Female participants of childbearing potential must have a negative pregnancy test before therapy and agree to use effective contraception for 1 year after treatment; male participants must also agree to use effective contraception for 1 year after treatment
- Prohibition on egg donation (females) and sperm donation (males) for 1 year after treatment infusion during the study
You will not qualify if you...
- Pregnant or lactating women
- Infection with HIV, syphilis, active hepatitis B or active hepatitis C
- Any current uncontrolled active infection including active tuberculosis
- Unresolved toxicities from previous treatment above Grade 1 (except alopecia or tolerable events)
- Treatment for lymphoma within 14 days prior to informed consent including cytotoxic therapy, monoclonal antibodies, targeted therapy, radiotherapy (except small bone marrow field), epigenetic therapy, or investigational agents/devices
- Systemic glucocorticoids equivalent to >15 mg/day prednisone within 7 days prior to consent (topical glucocorticoids allowed)
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks prior to consent
- Allergy or intolerance to preconditioning drugs, tocilizumab, or history of severe allergy such as anaphylaxis
- Heart disease within 6 months prior to screening
- Oxygen saturation below 92%
- Second primary malignancy requiring treatment or not in remission within 2 years
- Major surgery within 2 weeks before consent or planned during study or within 4 weeks after treatment (except local anesthesia)
- Inability or unwillingness to comply with study protocol or investigator assessment of unsuitability for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
Research Team
K
Kai Hu MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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